In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe - Archive ouverte HAL
Chapitre D'ouvrage Année : 2018

In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe

Résumé

This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.

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Dates et versions

halshs-01938345 , version 1 (28-11-2018)

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  • HAL Id : halshs-01938345 , version 1

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Aurélie Mahalatchimy, Anne-Marie Duguet, Wen Meng, Heidi Carmen Howard, Anne Cambon-Thomsen, et al.. In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe. Q. Yanping, A.-M. Duguet. Biotechnology Medicine and Law, China University of Political Science and Law Press, 2018, 978-7-5620-8420-4. ⟨halshs-01938345⟩
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